| K190167 — MitraClip G4 Steerable Guide Catheter | Abbott May 29, 2019 |
| K190474 — MectaLock PEEK Suture Anchor | Medacta International S.A. May 28, 2019 |
| K190686 — Optilite IgM CSF Kit | The Binding Site Group , Ltd. May 28, 2019 |
| K180739 — Clearlink System Solution Set | Baxter Healthcare Corporation May 28, 2019 |
| K190468 — Nihon Kohden SVM-7200 Series Vital Signs Monitor | Nihon Kohden Corporation May 28, 2019 |
| K182544 — AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. May 28, 2019 |
| K190482 — IGNITE Bone Void Filler | Wrightmedicaltechnologyinc May 28, 2019 |
| K190606 — Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | Kossan International Sdn Bhd May 28, 2019 |
| K182515 — Surgical Face Mask | Wuhan Dymex Healthcare Co., Ltd. May 27, 2019 |
| K183530 — TruDiagnosis System | Akonni Biosystems, Inc. May 24, 2019 |
| K190448 — LightLas Pattern Scanning System - TruScan Pro | Light-Med(Usa), Inc. May 24, 2019 |
| K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | Spectrum Medical , Ltd. May 24, 2019 |
| K190542 — Soliton Acoustic Wave Device | Soliton, Inc. May 24, 2019 |
| K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. May 24, 2019 |
| K181157 — Conical Plus Implant System | Osseofuse International, Inc. May 24, 2019 |
| K190603 — Tria Firm Ureteral Stent | Boston Scientific Corporation May 24, 2019 |
| K182575 — Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Jiangxi Jaysun Medcare Co., Ltd. May 24, 2019 |
| K190077 — Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove | Molnlycke Health Care Us, LLC May 24, 2019 |
| K191083 — COMPLETE CONTROL System Gen2 | Coapt, LLC May 24, 2019 |
| K190378 — Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix | Bioncise NV May 24, 2019 |
| K182321 — MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG May 24, 2019 |
| K190231 — InCore® Lapidus Sterile Kits | Nextremity Solutions, Inc. May 24, 2019 |
| K190802 — Envision ultrasound pad and cover | Civco Medical Solutions May 24, 2019 |
| K183054 — SYNMESH System | Depuy Synthes Spine May 23, 2019 |
| K183560 — Luna 3D GEN2 Interbody Fusion System | Benvenue Medical, Inc. May 23, 2019 |
| DEN180069 — ZIKV Detect 2.0 IgM Capture ELISA | InBios International, Inc. May 23, 2019 |
| K182458 — Longterm NPWT Foam Dressing Kit | Zhejiang Longterm Medical Technology Co., Ltd. May 23, 2019 |
| K182362 — MaxCap Ped and MaxCap Neo | Maxtec, LLC May 23, 2019 |
| K190018 — Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC May 23, 2019 |
| K190515 — Aptima Combo 2 Assay (Panther System) | Hologic, Inc. May 23, 2019 |
| K190441 — Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit | Cepheid May 23, 2019 |
| K182937 — Upstream GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. May 23, 2019 |
| K191091 — Rampart One Lumbar Interbody Fusion System | Spineology, Inc. May 23, 2019 |
| K183639 — Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation May 23, 2019 |
| K183654 — PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus | Pentax Of America, Inc. May 23, 2019 |
| K182390 — IMPEDE-FX Embolization Plug | Shape Memory Medical May 23, 2019 |
| DEN180032 — Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit | Cd Diagnostics, Inc. May 23, 2019 |
| K190436 — KATANA Zirconia Block | Kuraray Noritake Dental, Inc. May 23, 2019 |
| K190452 — Aptima BV Assay | Hologic, Inc. May 23, 2019 |
| K190469 — ERBEFLO 2 Disposable Tubing System | Erbe USA, Inc. May 23, 2019 |
| K191080 — Ambu aScope 4 RhinoLaryngo Slim | Ambu A/S May 22, 2019 |
| K183644 — Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions May 22, 2019 |
| K190823 — Erbe ESU Model VIO 3 with Accessories | Erbe Elektromedizin GmbH May 22, 2019 |
| K183611 — Soniquence RF Generator and Soniquence Electrodes | Soniquence, LLC May 22, 2019 |
| K190751 — Connector System | Orthofix, Inc. May 22, 2019 |
| K190769 — Bladder Scanner (Models: M2, M2-W, M1, M1-W) | Suzhou Lischka Medtech Co., Ltd. May 22, 2019 |
| K190444 — HERA I10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. May 22, 2019 |
| K190902 — RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope | Wenzhou Renhua Instruments Co., Ltd. May 22, 2019 |
| K182350 — Dental Ceramic | Baot Biological Technology Co., Ltd. May 22, 2019 |
| K182374 — LIAC S | Sit Sordina Iort Technologies Spa May 22, 2019 |